Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of SBP in Patients With LC

Phase 4

Completed

• Conditions: SBP; Liver Cirrhosis
• Interventions: Drug: Cefotaxime; Drug: Ceftriaxone; Drug: Ciprofloxacin

• Registration Number: NCT01265173
• Lead Sponsor: Korea University

Brief Summary

Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.

The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. This is non-inferiority trial.

Detailed Description

Spontaneous bacterial peritonitis (SBP) is one of the most serious complications of liver cirrhosis. Mainstay of treatment for SBP is use of proper antibiotics. Although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. Our aim of study is to compare the efficacy of the three current antibiotics for the treatment of SBP in patients with liver cirrhosis.

The primary hypothesis is that the efficacy of all the antibiotics will not significantly different. The expected success rates (infection resolution rates) are 83%, 87%, and 78% for cefotaxime, ceftriaxone, and ciprofloxacin. This is non-inferiority trial. The level of significance is 5%. The power of this stuy is 80%. Non-inferiority margin is 15%. Therefore 87 patients for each group are needed.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-23
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

1. Liver cirrhosis patients with ascites
2. Ascitic fluid PMN cell count >250/mm3
3. Age: 16~70 years old

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Exclusion Criteria

1. Allergic to 3rd generation cephalosporin or quinolone
2. Antibiotics within 2 weeks
3. Open abdominal surgery within 4 weeks
4. Evidence of 2ndary peritonitis, intrabdominal hemorrhage, pancreatitis, Tb peritonitis, or peritoneal carcinomatosis
5. HCC with portal vein thrombosis
6. Pregnant woman
7. HIV positive

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefotaxime	Cefotaxime	iv 2G q 8hrs for general, dose titration if needed (eg.CKD)
Ceftriaxone	Ceftriaxone	iv 2G q 24hrs
Ciprofloxacine	Ciprofloxacin	iv 400mg q 12hrs for general, dose titration if needed (eg.CKD)

Primary Outcome Measures

Name	Time	Method
Infection resolution rates within 5 days of treatment	5 days (120 hours)	PMN \< 250/mm3 from ascitic fluid

Secondary Outcome Measures

Name	Time	Method
Mortality & recurrence rates within 1 month	1 month	Mortality

Trial Locations

Locations (2)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Ansan Hospital; 🇰🇷 Ansan, Korea, Republic of